Coya Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents totaled $35.8 million as of September 30, 2026, down from $46.8 million as of December 31, 2025.
• Collaboration revenue for the three months ended September 30, 2026, was $0.2 million, compared to $3.6 million for the same period in 2025.
• Research and development expenses increased to $8.6 million for the three months ended September 30, 2026, from $2.9 million in the prior year period, driven by a $5.6 million increase in preclinical and clinical product candidate costs.
• General and administrative expenses remained flat at $2.6 million for the three months ended September 30, 2026, compared to $2.6 million in 2025.
• Net loss for the three months ended September 30, 2026, was $10.6 million, compared to a net loss of $2.1 million in the same period of 2025.
• Net loss per share (basic and diluted) was $0.45 for the three months ended September 30, 2026, compared to $0.13 in 2025.
• For the nine months ended September 30, 2026, net cash used in operating activities was $20.8 million, compared to $9.7 million in 2025.
• Net cash provided by financing activities for the nine months ended September 30, 2026, was $10.7 million, primarily from the sale of common stock, compared to $38,274 in 2025.
• Total assets were $39.3 million as of September 30, 2026, down from $50.0 million as of December 31, 2025.
• Total stockholders' equity was $33.6 million as of September 30, 2026, down from $43.0 million as of December 31, 2025.
• Accumulated deficit increased to $86.4 million as of September 30, 2026, from $62.0 million as of December 31, 2025.

Guidance and Future Outlook:

• Topline data from the Phase 2/3 ALSTARS trial is anticipated in early Q2 2027.
• Additional mechanistic data and single-cell proteomics data from completed ALS and AD investigator-initiated trials are expected in Q4 2026 to Q1 2027, subject to publication.
• Biomarker data from the completed investigator-initiated study in frontotemporal dementia (FTD) patients is expected in Q1 2027.
• A Phase 2 study evaluating COYA 302 for the treatment of FTD is planned to initiate in 2027.
• Current cash reserves are sufficient to fund operations past the ALSTARS topline data readout and into the second half of 2027.

Business Segments and Product Lines:

• Completed enrollment of 137 participants in the Phase 2/3 ALSTARS trial for COYA 302, exceeding the planned 120 participants.
• Announced plans to initiate an open-label extension (OLE) of the ALSTARS trial for participants who complete the 48-week study period.
• Published preclinical results for COYA 303 in the International Journal of Molecular Sciences demonstrating complementary immunomodulatory effects in a CNS inflammation model.
• Presented Neurofilament Light Chain (NfL) Biomarker Stratification Methodology at the 2026 Annual NEALS Meeting.
• COYA 302 is an investigational biologic combination therapy comprising low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig for subcutaneous administration.
• COYA 303 is an investigational product candidate with demonstrated immunomodulatory effects in preclinical models.

Market and Competitive Landscape:

• The company is developing treatments for neurodegenerative disorders, specifically ALS and FTD, targeting systemic and neuroinflammation.
• COYA 302 has received FDA Fast Track designation.
• The ALSTARS trial is a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study (Identifier: NCT07161999).
• The trial design includes a 24-week placebo-controlled treatment period followed by a second blinded 24-week period, with all subjects invited to an ongoing open-label extension.

Risks and Challenges:

• Product candidates are investigational and not yet approved by the FDA or any other regulatory agency.
• Forward-looking statements regarding data timing, trial results, and financial position are subject to known and unknown risks and uncertainties.
• Actual results may differ from current expectations due to factors discussed in the Company's SEC filings, including the "Risk Factors" section of the Form 10-K for the year ended December 31, 2025.

Management Commentary and Tone:

• CEO Arun Swaminathan, Ph.D., stated that completing enrollment in the ALSTARS trial is a significant achievement and emphasized the focus on communicating data as soon as it is available.
• President and Chief Medical Officer Fred Grossman, DO, FAPA, described the completion of the ALSTARS trial as an important milestone and noted the value of the open-label extension for data collection and patient continuity.
• Management expressed confidence in the dosing schedule revision for the ALSTARS trial, believing it will have no impact on potential efficacy or safety.

Other Key Points:

• The company raised $10.9 million from the sale of common stock, net of offering costs, during the nine months ended September 30, 2026.
• In-process research and development expenses were $23,240 for the three months ended September 30, 2026, compared to $0.5 million in 2025, which was attributed to milestone payments upon FDA IND acceptance.
• No milestone payments pursuant to license agreements were incurred during the three months ended September 30, 2026.
• The company has no Series A convertible preferred stock issued or outstanding.
• Common stock issued and outstanding increased to 23,457,849 shares as of September 30, 2026, from 20,934,456 shares as of December 31, 2025.